RecruitingPhase 2NCT06594991

A Study of Fianlimab, Cemiplimab, and Ipilimumab in People With Melanoma

A Phase 2 Study of Fianlimab, Cemiplimab, and Ipilimumab in Anti-PD-1 Refractory Melanoma

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

88 participants

Start Date

Sep 10, 2024

Study Type

INTERVENTIONAL

Conditions

Advanced Melanoma

Summary

The purpose of this study is to test whether the combination of fianlimab, cemiplimab, and ipilimumab is a safe and effective treatment that causes few or mild side effects for locally advanced or metastatic, unresectable, refractory melanoma.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a triple immunotherapy combination — fianlimab, cemiplimab, and ipilimumab — for people with advanced melanoma whose cancer has progressed despite previous immunotherapy treatment. **You may be eligible if...** - You are 18 or older - You have been diagnosed with stage III (unresectable) or stage IV melanoma (skin or mucosal) - Your melanoma has progressed on prior immunotherapy: - Cohort A: progressed on a PD-1 inhibitor alone - Cohort B: progressed on a combination of PD-1 and LAG-3 inhibitors - You have measurable disease on imaging **You may NOT be eligible if...** - You have ocular (eye) melanoma - Your cancer has not progressed on the required prior immunotherapy - You have active brain metastases or other serious uncontrolled conditions - You have a serious autoimmune condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFianlimab

Fianlimab IV given every three weeks

DRUGCemiplimab

Cemiplimab IV given every three weeks

DRUGIpilimumab

Ipilimumab will be give every 6 weeks continuously

Locations(12)

Cedars-Sinai Medical Center

Los Angeles, California, United States

Stanford University (Data Collection Only)

Stanford, California, United States

Hartford Healthcare Alliance (Data Collection Only)

Hartford, Connecticut, United States

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, United States

Hackensack Meridian Health (Data Collection Only)

Hackensack, New Jersey, United States

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

MD Anderson Cancer Center (Data Collection Only)

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06594991

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